Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Neurological Deficit/Dysfunction (1982); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
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Event Description
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It was reported that on an unknown date, patient with lumbar canal stenosis underwent surgery in which the spacer was implanted.The surgeon reported that metallosis was observed in patient after the removal of the spacer.The hospital¿s inspection revealed the suspicion of metal component.The contaminated part was cut.
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Event Description
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Neurological symptom was developed which would lead to the revision surgery.
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Search Alerts/Recalls
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